Topivac
by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 19 variants
Ref ATPVSO3EMModel OZONE BAG
Topivac (ATPVSO3EM) is a Class IIb device made by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-08683161110430), active as of 7 Nov 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08683161110430 08683161110430 | Date28 Oct 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08683161110430 08683161110430 | Date28 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-08683161110430
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device name
- Ozonebag Medium Hand / Arm
- Model / reference
- OZONE BAG, ATPVSO3EM
- Primary DI / UDI-DI
- 08683161110430
- Basic UDI-DI
- B-08683161110430, 868316111OZONBAG27
- Direct marketing DI
- 08683161110430
- EMDN code
- Z12019003 Wound treatment equipment
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- TR-MF-000016889
Similar devices in this category
Other devices filed under WOUND TREATMENT EQUIPMENT.
- UNO 7 Therapy Kit 15x15 U-S1515-4 by GENADYNE BIOTECHNOLOGIES INC.
- AVELLE 422285 by CONVATEC, PURCHASING DEPARTMENT
- AnsCare SIMO NP-1-2 by BENQ MATERIALS CORP.
- VivereX+™ NPWT pump PDI600400 by Sunmedic AB
- AnsCare SIMO NP-3-1 by BENQ MATERIALS CORP.
- JetPeel BiPhasic HP JBPH-001 by TAV - TECH LTD
- UNO 7 Therapy Kit 20x20 U-S2020-4 by GENADYNE BIOTECHNOLOGIES INC.
- AVELLE 446650 by CONVATEC, PURCHASING DEPARTMENT
- PLASMO®HEAL PRO Applicator Tube 3014 by WK-MedTec GmbH
- NATROX® Oxygen Wound Therapy Oxygen Delivery System NA055-30 by Inotec Amd, Ltd.
Other devices from Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →